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顺铂、异环磷酰胺和阿霉素治疗可手术的原发性、中轴骨和转移性骨肉瘤的II期研究。欧洲骨肉瘤协作组(EOI)。

A phase II study of cisplatin, ifosfamide and doxorubicin in operable primary, axial skeletal and metastatic osteosarcoma. European Osteosarcoma Intergroup (EOI).

作者信息

Voûte P A, Souhami R L, Nooij M, Somers R, Cortés-Funes H, van der Eijken J W, Pringle J, Hogendoorn P C, Kirkpatrick A, Uscinska B M, van Glabbeke M, Machin D, Weeden S

机构信息

Emma Kinderziekenhuis, Academic Medical Center, Amsterdam, The Netherlands.

出版信息

Ann Oncol. 1999 Oct;10(10):1211-8. doi: 10.1023/a:1008361612767.

DOI:10.1023/a:1008361612767
PMID:10586339
Abstract

BACKGROUND

Despite advances in the treatment of primary limb osteosarcoma, the outcome of patients with primary metastatic and axial skeletal disease remains poor. The European Osteosarcoma Intergroup have assessed a combination chemotherapy regimen consisting of ifosfamide (IFOS) 3 g/m2/dl-2, doxorubicin (DOX) 25 mg/m2/dl-3 i.v. bolus and cisplatin (CDDP) 100 mg/m2/dl.

PATIENTS AND METHODS

One hundred nine previously untreated patients with primary osteosarcoma were registered. Eligibility was confirmed in 103. At presentation, 45 eligible patients had metastatic disease, 15 axial skeletal primary tumours and 43 non-metastatic limb tumours.

RESULTS

The major toxicities were myelosuppression (90%, grade 3 or 4) and nausea and vomiting (74%, grade 3 or 4). Overall mean relative dose intensity (RDI) was 80% (88% CDDP, 75% IFOS, 81% DOX). Clinical response as measured by reduction in tumour volume occurred in 36% (95% confidence interval (95% CI): 27%-47%) of primary tumours. Response of pulmonary metastases to chemotherapy was seen in 33% (95% CI: 19%-49%). Good histological response (> or = 90% necrosis of the tumour) occurred in 33% (95% CI: 22%-45%) of resected tumours. Five-year survival was 62% in limb-non-metastatic, 41% in axial skeletal and 16% in limb metastatic patients.

CONCLUSIONS

This regimen is active in osteosarcoma but does not appear to be more active than the two-drug CDDP-DOX regimen currently recommended by EOI.

摘要

背景

尽管原发性肢体骨肉瘤的治疗取得了进展,但原发性转移性和轴向骨骼疾病患者的预后仍然很差。欧洲骨肉瘤协作组评估了一种联合化疗方案,该方案包括异环磷酰胺(IFOS)3g/m²/dl - 2、阿霉素(DOX)25mg/m²/dl - 3静脉推注和顺铂(CDDP)100mg/m²/dl。

患者与方法

登记了109例先前未接受过治疗的原发性骨肉瘤患者。103例符合条件。就诊时,45例符合条件的患者有转移性疾病,15例有轴向骨骼原发性肿瘤,43例有非转移性肢体肿瘤。

结果

主要毒性为骨髓抑制(90%,3级或4级)以及恶心和呕吐(74%,3级或4级)。总体平均相对剂量强度(RDI)为80%(顺铂88%,异环磷酰胺75%,阿霉素81%)。以肿瘤体积缩小衡量的临床反应在36%(95%置信区间(95%CI):27% - 47%)的原发性肿瘤中出现。肺转移对化疗的反应见于33%(95%CI:19% - 49%)。切除的肿瘤中有33%(95%CI:22% - 45%)出现良好的组织学反应(肿瘤坏死≥90%)。肢体非转移性患者的5年生存率为62%,轴向骨骼患者为41%,肢体转移性患者为16%。

结论

该方案对骨肉瘤有活性,但似乎并不比欧洲骨肉瘤协作组目前推荐的两药顺铂 - 阿霉素方案更有活性。

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